AstraZeneca said the US Food and Drug Administration (FDA) has accepted the biologics license application for Moxetumomab Pasudotox, used to treat hairy-cell leukaemia in adults.
The FDA has also granted the medicine priority-review status.
The European Medicines Agency will review AstraZeneca’s marketing authorisation application for Lynparza, representing the first regulatory submission for a poly ADP-ribose polymerase inhibitor for breast cancer in Europe.
Lynparza is used for patients who have metastatic breast cancer and have been treated with chemotherapy.
Shares in AstraZeneca fell 0.7% to 4,858p in morning trading.